NCT01552395

Brief Summary

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,136

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

68 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

4.1 years

First QC Date

March 7, 2012

Last Update Submit

May 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    24 months

Secondary Outcomes (1)

  • Number of changes in dosage regime

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Patients Suffering From Nocturia 1x or More Times a Night

You may qualify if:

  • nocturia

You may not qualify if:

  • habitual or psychogenic polydipsia,
  • known or suspected cardiac insufficiency
  • other conditions requiring treatment with diuretics
  • moderate and severe renal insufficiency
  • known hyponatremia
  • syndrome of inappropriate ADH secretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (68)

Nemocnice Rudolfa a Stefanie (there may be other sites in this country)

Benešov, Czechia

Location

Soukromá ambulance, Benešov

Benešov, Czechia

Location

Soukromá ambulance Beroun

Beroun, Czechia

Location

Slezská urologie

Bohunín, Czechia

Location

URIONTEGRITAS soukromá ambulance

Brno, Czechia

Location

Uro - clinic

Brno, Czechia

Location

Urocentrum Brno

Brno, Czechia

Location

Úrazová nemocnice Brno

Brno, Czechia

Location

Soukromá ambalance

Citonice, Czechia

Location

Domažlická Nemocnice

Domažlice, Czechia

Location

Městská nemocnice Dvůr Králové nad Labem a.s.

Dvůr Králové nad Labem, Czechia

Location

Nemocnice s poliklinkou Havířov

Havířov, Czechia

Location

Nemocnice Havlíčkův Brod

Havlíčkův Brod, Czechia

Location

Gynekologická ambulance Hluk

Hluk, Czechia

Location

Fakultní nemocnice Hradec Králové

Hradec Králové, Czechia

Location

PPCHC Sanus Hradec Králové

Hradec Králové, Czechia

Location

Městská nemocnice Hustopeče

Hustopeče U Brna, Czechia

Location

Urologická ambulance UROLA

Jaroměř, Czechia

Location

Soukromá ambulance, Jilemnice

Jilemnice, Czechia

Location

Oblastní nemocnice Kladno a.s.

Kladno, Czechia

Location

Urologie s.r.o.

Klatovy, Czechia

Location

Soukromá ambulance Krnov

Krnov, Czechia

Location

Kromerizska nemocnice a.s.

Kroměříž, Czechia

Location

Soukromá ambulance, Lanškroun

Lanškroun, Czechia

Location

Soukromá ambulance Mohelnice

Mohelnice, Czechia

Location

Oblastní nemocnice Náchod

Náchod, Czechia

Location

Sourkomá ambulance, Nový Jičín

Nový Jičín, Czechia

Location

Nemocnice Nový Jičín

Nový Jíčín, Czechia

Location

Centrum MEDIOL s.r.o.

Olomouc, Czechia

Location

FN Olomouc

Olomouc, Czechia

Location

Městská nemocnice Ostrava

Ostrava, Czechia

Location

Gynekologická ambulance

Ostrava Ploskovice, Czechia

Location

Vítkovická Nemocnice a.s.

Ostrava-Vítkovice, Czechia

Location

Nemocnice Pelhřimov

Pelhřimov, Czechia

Location

FN Plzeň

Pilsen, Czechia

Location

Poliklinika Denisovo nábřeží

Pilsen, Czechia

Location

Nemocnice Písek

Písek, Czechia

Location

Urologická ambulance

Prachatice, Czechia

Location

FN Bulovka

Prague, Czechia

Location

Medicon

Prague, Czechia

Location

Nemocnice s poliklinikou Praha Italská

Prague, Czechia

Location

Soukromá ambulance Praha 7

Prague, Czechia

Location

Soukromá ambulance, Praha 5

Prague, Czechia

Location

Urocare

Prague, Czechia

Location

Urologická klinika Praha 1

Prague, Czechia

Location

Urologické oddělení

Prague, Czechia

Location

Urologie Zahradní Město s.r.o.

Prague, Czechia

Location

Urosanté s.r.o

Prague, Czechia

Location

VFN

Prague, Czechia

Location

Ústřední vojenská nemocnice

Prague, Czechia

Location

Urologie - NZZ Lékařský dům

Praha 10 - Uhříněves, Czechia

Location

JR Urocentrum Přerov s.r.o.

Přerov, Czechia

Location

Soukromá ambulance, Přeštice

Přeštice, Czechia

Location

Urocare s.r.o.

Říčany, Czechia

Location

Soukromá ambulance Štemberk

Štemberk, Czechia

Location

Nemocnice Tábor

Tábor, Czechia

Location

Krajská zdravotní - nemocnice Teplice

Teplice, Czechia

Location

Urologická ambulance

Trutnov, Czechia

Location

Nemocnice Třebíč

Třebíč, Czechia

Location

Nemocnice Podlesí a.s.

Třinec, Czechia

Location

Městská nemocnice Turnov

Turnov, Czechia

Location

Nemocnice Uherské Hradiště

Uherské Hradiště, Czechia

Location

Masarykova nemocnice v Ústí nad Labem

Ústí nad Labem, Czechia

Location

Nemocnice Valašské Meziříčí

Valašské Meziříčí, Czechia

Location

DUAM s.r.o. Lékařský dům

Zlín, Czechia

Location

Krajská nemocnice T.Bati a.s.

Zlín, Czechia

Location

Soukromá ambulance, Zlín

Zlín, Czechia

Location

UROKAN s.r.o.

Znojmo, Czechia

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations